BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ TUBING SET

    MDR report key: 3960078 · Received June 23, 2014

    Report

    Report Number
    3006697299-2014-00055
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LBK
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    AT THE INCOMING INSPECTION OF GOODS, THE DISTRIBUTOR FOUND A BLACK FOREIGN MATERIAL OR SCARRING INSIDE THE PACKAGING, POSSIBLY ON THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364580 CUSA EXCEL 23KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LBK INTEGRA LIFESCIENCES (IRELAND) LIMITED 1140204

    Patients

    Seq Age Sex Outcome Treatment
    1